Cancer Genetics, Inc. Receives New York State Approval for Focus::CLL™, a Unique NGS Panel for Chronic Lymphocytic Leukemia, Reinforcing the Company’s Market-Leading Position in the Diagnosis and Management of B-Cell Cancers

Published 7:30 AM ET Thu, 30 June 2016
Globe Newswire

Focus::CLL™ is the only CLIA-validated and NYS-approved NGS panel for CLL that offers information for patient risk stratification, disease management, and treatment selection

Focus::CLL™ addresses a significant market of over 120,000 patients in the US living with CLL, the most common form of leukemia in the Western hemisphere accounting for one-third of all newly diagnosed cases

RUTHERFORD, N.J., June 30, 2016 (GLOBE NEWSWIRE) -- Cancer Genetics, Inc. (Nasdaq:CGIX) (“CGI” or “The Company”), a leader in enabling precision medicine for oncology through molecular markers and diagnostics, announced today that it received New York State approval for its Focus::CLL™ panel, a unique next generation sequencing (NGS)-based panel for chronic lymphocytic leukemia (CLL) and small lymphocytic lymphoma (SLL).

"This approval is a testament to CGI's ability to provide NGS panels that meet the highest quality standards. Focus::CLL™ is a highly focused panel that is available for patient diagnosis and management as well as for CLL clinical trials," said CGI President and CEO, Panna Sharma. "In fact, Focus::CLL™ is currently being used in multiple global clinical trials by leading biotech and pharmaceutical companies to aid in patient monitoring and disease understanding."

The panel assesses seven genes with clinical relevance for prognosis, disease management, and treatment selection. The genes included in the panel are TP53, ATM, BIRC3, NOTCH1, SF3B1, CARD11, and MYD88. The targeted NGS panel offers actionable and immediately relevant information for clinicians. With superior analytical sensitivity, the test is able to detect biomarker mutations and aberrations that are present at very low levels and which may be missed by other, less sensitive methodologies. Improved sensitivity can lead to enhanced diagnostic and prognostic capabilities for CLL and improved patient outcomes. In addition to being available as an individual test, Focus::CLL™ is integrated into the company’s Complete™ offering for CLL and SLL.

CLL accounts for roughly one-third of all newly diagnosed leukemia cases. Over 15,000 new cases are diagnosed in the U.S. each year, and an estimated 120,000 individuals are currently living with the disease. Recent advances in treatment for CLL have been significant, including the FDA approval of idelalisib and ibrutinib for the disease, but due to tumor heterogeneity, precisely prognosing CLL has remained a challenge. Focus::CLL™ responds to this challenge by providing a comprehensive view of the tumor’s genomic profile, detecting mutations with relevance for prognosis and treatment selection. Focus::CLL™ is the only clinically available NGS panel that assesses these seven biomarkers with a single test.

ABOUT CANCER GENETICSCancer Genetics Inc. is a leader in enabling precision medicine in oncology from bench to bedside through the use of oncology biomarkers and molecular testing. CGI is developing a global footprint with locations in the US, India and China. We have established strong clinical research collaborations with major cancer centers such as Memorial Sloan Kettering, The Cleveland Clinic, Mayo Clinic, Keck School of Medicine at USC and the National Cancer Institute.

The Company offers a comprehensive range of laboratory services that provide critical genomic and biomarker information. Its state-of-the-art reference labs are CLIA-certified and CAP-accredited in the US and have licensure from several states including New York State.

Forward-Looking Statements: This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. All statements pertaining to Cancer Genetics Inc.’s expectations regarding the completion, timing, pricing and size of the offering described in this press release constitute forward-looking statements.

Any statements that are not historical fact (including, but not limited to, statements that contain words such as "will," "believes," "plans," "anticipates," "expects," "estimates") should also be considered to be forward-looking statements. Forward-looking statements involve risks and uncertainties, including, without limitation, risks inherent in the development and/or commercialization of potential products, risks of cancellation of customer contracts or discontinuance of trials, risks that anticipated benefits from acquisitions will not be realized, uncertainty in the results of clinical trials or regulatory approvals, need and ability to obtain future capital, maintenance of intellectual property rights and other risks discussed in the Cancer Genetics, Inc. Form 10-K for the year ended December 31, 2015 and the Form 10-Q for the Quarter ended March 31, 2016 along with other filings with the Securities and Exchange Commission. These forward-looking statements speak only as of the date hereof. Cancer Genetics, Inc. disclaims any obligation to update these forward-looking statements.